Phase II Trial of Rituximab Plus 2CdA in Patients with Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

Overview

No summary available.

Registry

who.int

Start Date

April 7, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Histologically proven diagnosis of MALT lymphoma of any localization.
•Disseminated disease upon diagnosis in case of gastric lymphoma or first or greater relapse after local therapy (including gastrectomy or surgery), prior chemotherapy or HP\-eradication.
•Measurable disease.
•ECOG performance status of 0, 1 or 2\.
•Age of at least 18 years.
•Life expectancy of at least 3 months.
•Adequate cardiac, renal and liver function tests (LVEF \> 50%, serum creatinine \< 2\.5 mg/dl, ALAT or ASAT \< 2\.5x ULN, alkaline phosphatase \< 2\.5xULN, serum bilirubine \< 2\.0 mg/dl)
•Patient must be willing and able to comply woth the protocol for the entire study duration.
•Women of child\-bearing potential must have a negative pregnancy test and must agree to use effective contraception for the entire treatment period
•Patient's written informed consent.

•Lymphoma histology other than MALT lymphoma or MALT lymphoma transforming to diffuse large cell lymphoma (high grade lymphoma).
•Use of any investigational agent in the month prior to inclusion.
•History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years.
•Major surgery, other than diagnostic surgery, within the last 4 weeks.
•Evidence of CNS involvement.
•A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs.
•Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months.
•Inadequate hematological status at baseline prior to study entry: dependency on red blood cell and/or platelet transfusions, ANC (absolute neutrophile count (segmented \+ bands) \< 1\.0 x 10E9/L.
•Patients with active opportunistic infections.
•Pregnancy or lactation.